Acoustic + Electrical Stimulation for Tinnitus

Overseen By Hamid Djalilian, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Irvine

Must not be taking: Aspirin, Ibuprofen, Naproxen

Disqualifiers: Illicit drug use, Alcohol dependence, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to treat tinnitus, the experience of ringing or other noises in the ears without external sound. Researchers are testing sound-based (acoustic) and electrical approaches to determine if these can reduce or eliminate tinnitus symptoms. Participants will experience various sound and electrical signals to assess their impact on tinnitus loudness. Individuals who have experienced tinnitus for six months or more and can communicate well in English may be suitable for this trial. The ultimate goal is to develop a reliable treatment for tinnitus to enhance the quality of life for those affected. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to innovative treatments for tinnitus.

Do I need to stop taking my current medications for the trial?

If you are taking medications known to cause tinnitus, like aspirin, ibuprofen, or naproxen, you must be able to stop them to participate in the trial. Otherwise, the protocol does not specify if you need to stop other medications.

What prior data suggests that this acoustic and electrical stimulation is safe for tinnitus treatment?

Research has shown that both sound and electrical treatments are being explored for tinnitus relief, and they appear safe. In one study on electrical treatment, 63% of participants experienced reduced ear ringing. The study found no serious side effects, indicating the treatment is generally safe. Another study reported that after three days of electrical treatment, 47% of participants noted quieter ringing, 45.5% observed no change, and 7.6% reported worsening symptoms.

These findings suggest that electrical treatment is mostly safe, with most participants experiencing improvement or no change. Sound treatment, which involves listening to sounds through headphones, is also safe and non-invasive. Overall, both treatments seem well-tolerated, though individual experiences may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combination of acoustic and electrical stimulation for tinnitus because it offers a novel approach by simultaneously using sound and mild electrical impulses to target the brain's auditory pathways. Unlike traditional treatments that often focus on masking the tinnitus sound or using medications to manage symptoms, this method aims to retrain the brain to reduce the perception of tinnitus noise. This dual-modality approach could provide more effective and longer-lasting relief for those suffering from this condition.

What evidence suggests that acoustic and electrical stimulation could be effective for tinnitus?

Research has shown that electrical stimulation can help reduce tinnitus, and in some cases, it might even eliminate it completely. One study found that 63% of patients experienced some relief from their tinnitus after receiving electrical stimulation. Additionally, applying electrical stimulation directly inside the ear improved symptoms, especially for those with a constant ringing sound. This trial will explore the combination of sound therapy with electrical stimulation, which might enhance effectiveness, though further research is needed to confirm this. Overall, these methods appear promising as potential treatments for tinnitus. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for adults who have had tinnitus, or ringing in the ears, for at least six months. Participants must speak English well enough to describe their experiences and complete surveys. Those with cochlear implants can join the electrical stimulation part of the study. Excluded are individuals under 18, pregnant or breastfeeding women, those on certain medications like aspirin that cause tinnitus, with ear abnormalities or treatable causes of tinnitus.

Inclusion Criteria

To be able to accurately describe the unusual sensations caused by electrical stimulation, and to be able to complete surveys about them.

I am either male or female.

I have had ringing in my ears for over 6 months.

Exclusion Criteria

I have a long-term ear infection.

I have issues with my ear canal or ear drum.

My tinnitus can be treated.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo acoustic and electrical stimulation to evaluate tinnitus suppression

12 months

Multiple visits throughout the year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Acoustic
• Electrical

Trial Overview The study investigates acoustic and electrical stimulation as treatments for tinnitus. Acoustic tests involve listening to sounds through headphones and rating tinnitus loudness. Electrical tests use a cochlear implant or electrodes placed in/on the ear to assess changes in tinnitus perception.

How Is the Trial Designed?

Group I: Electrical/ Acoustic stimulation Experimental Treatment 2 Interventions

Acoustic is already approved in United States, European Union for the following indications:

Approved in United States as Electrical Stimulation Therapy for:

• Tinnitus suppression
• Tinnitus management

Approved in European Union as Electrical Stimulation Therapy for:

• Tinnitus treatment
• Tinnitus relief

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

Published Research Related to This Trial

Transcutaneous electrical stimulation using the Theraband Headset has shown effectiveness in suppressing tinnitus in select patients, particularly those with peripheral lesions and cochlear-type tinnitus.

Successful patient selection is crucial for treatment efficacy, requiring specific clinical criteria such as positive maskability of tinnitus and absence of active ear disease, indicating that not all tinnitus patients may benefit from this approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

External electrical tinnitus suppression: a review. Shulman, A.[2006]

Electrical stimulation can effectively reduce tinnitus symptoms in approximately 50% of patients, regardless of the underlying cause of their tinnitus.

The treatment is considered safe when administered according to the specified guidelines in the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tinnitus reduction using transcutaneous electrical stimulation. Steenerson, RL., Cronin, GW.[2019]

In a study of 22 patients with tinnitus, transcutaneous electrical nerve stimulation (TENS) showed statistically significant improvements in various quality of life measures, including emotional health and social functioning, indicating its potential effectiveness in managing tinnitus symptoms.

While the overall improvement in tinnitus severity measured by the visual analogue scale was only marginally significant, TENS was associated with notable enhancements in patients' quality of life, suggesting it could be a beneficial treatment option for those affected by tinnitus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of tinnitus with transcutaneous electrical nerve stimulation improves patients' quality of life. Aydemir, G., Tezer, MS., Borman, P., et al.[2008]

Transcutaneous electrical nerve stimulation (TENS) significantly reduces tinnitus severity, as shown by a decrease in Tinnitus Handicap Inventory (THI) scores by an average of -7.55 and Visual Analog Scale (VAS) scores by -0.65, based on a meta-analysis of 1,215 patients across 17 studies.

Approximately 40% of patients reported subjective improvement in tinnitus after TENS treatment, with 22.2% experiencing complete suppression and 10.2% showing persistent improvement at 3 months, indicating TENS is a safe and effective option for managing tinnitus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Electrical Nerve Stimulation for Treatment of Tinnitus: A Systematic Review and Meta-analysis. Byun, YJ., Lee, JA., Nguyen, SA., et al.[2021]

Transcutaneous electrical stimulation using square waves can significantly improve severe tinnitus in about one-third of patients, but the treatment needs to be repeated two to three times for effectiveness.

If no notable improvement is observed after two or three sessions, it is likely that the treatment will not be successful, although the exact mechanism behind the improvement remains unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of tinnitus by mean of electric transcutaneous stimulation (author's transl)]. Chouard, CH., Maridat, D., Lacombe, H., et al.[2006]

In a study of 46 individuals with chronic subjective tinnitus, TENS therapy significantly reduced tinnitus severity and improved quality of life measures after 20 sessions over 4 weeks, with a notable decrease in loudness and annoyance levels (p = 0.003).

The control group, which did not receive TENS therapy, showed no significant changes in tinnitus severity or quality of life, highlighting the effectiveness of TENS as a therapeutic intervention for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Electric Nerve Stimulation in Chronic Subjective Tinnitus. Aydoğan, Z., Satekin, MC., Uyar, MS., et al.[2022]

Transcutaneous electrical stimulation (TENS) significantly alleviates tinnitus symptoms, with 62.2% of patients reporting improvement after treatment, as measured by the Tinnitus Handicap Inventory (THI) and visual analog scale (VAS).

The effectiveness of TENS is particularly notable in patients with low-frequency tinnitus and mild hearing loss, suggesting that these characteristics may predict better responses to this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of transcutaneous electrical stimulation for chronic tinnitus. Lee, SK., Chung, H., Chung, JH., et al.[2022]

In a study involving 500 patients with various causes of tinnitus, 53% experienced a reduction in their tinnitus symptoms after receiving 6 to 10 sessions of electrical stimulation treatment.

The treatment showed lasting benefits, with 72% of patients maintaining their improvement at a 3-month follow-up, although there were some cases of temporary or permanent increases in tinnitus for a few patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of tinnitus with electrical stimulation. Steenerson, RL., Cronin, GW.[2017]

Transcutaneous electric stimulation using square waves can lead to significant improvement in about one-third of severe tinnitus cases, with treatment sessions lasting only a few minutes.

For optimal results, this stimulation should be repeated two to three times, but if no improvement is seen after these attempts, it is unlikely to be effective, although the exact mechanism behind the improvement remains unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrotherapy for severe tinnitus. Chouard, CH., Meyer, B., Maridat, D.[2019]

Transcutaneous electrical nerve stimulation (TENS) applied to the auricula significantly reduced tinnitus severity and associated anxiety and stress levels in a study of 60 patients, with results showing a notable difference compared to a placebo group.

Both one-ear and two-ear TENS treatments were effective, but there was no significant difference in efficacy between the two methods, indicating that TENS can be a viable treatment option for chronic subjective tinnitus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of transcutaneous electrical nerve stimulation (TENS) on chronic subjective tinnitus. Tutar, B., Atar, S., Berkiten, G., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8442493/

Electrical stimulation to treat tinnitus: a meta-analysis and ... Conclusion: Overall, electrical stimulation may be an effective and well-tolerated treatment option for tinnitus. Keywords: electrical stimulation, meta- ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6330726/

Tinnitus Treatment Using Noninvasive and Minimally Invasive ... The preliminary results showed that 63% of conditions of electric stimulation produced some degree of tinnitus reduction, with total disappearance of tinnitus ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04551404

Transcranial Electrical and Acoustic Stimulation for Tinnitus Results were indicative of a superior efficacy of combined electrical and acoustic approaches, while large-scale controlled studies have not been performed.

4. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2022.885263/full

The Effectiveness of Targeted Electrical Stimulation via ... Targeted intracochlear electrical stimulation improved chronic tinnitus perception, especially in monotone tinnitus, and the apical region was mainly involved.

5. mdpi.com mdpi.com/2077-0383/13/9/2663

Electrical Ear Canal Stimulation as a Therapeutic ... Results: After three days of electrical stimulation, tinnitus loudness decreased in 47% of patients, 45.5% reported no change, and 7.6% reported worsening.

6. es.aetna.com es.aetna.com/cpb/medical/data/400_499/0406.html

Tinnitus Treatments - Medical Clinical Policy Bulletins The authors reported that 53 % of patients showed decreases in their tinnitus as measured by a subjective rating scale. At 3-month follow-up, 72 % had no loss ...